A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
- Conditions
- Locally Advanced Cervical Cancer
- Interventions
- Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy
- Registration Number
- NCT06237257
- Lead Sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Brief Summary
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 56
- Able and willing to provide a written informed consent
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
- Has locally advanced cervical cancer；
- At least one measurable lesion ( RECIST version 1.1)；
- Investigator assess it is suitable for concurrent chemoradiotherapy;
- Has provided a tissue sample from tumor lesion;
- Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- BMI≥18.5kg/m2；
- Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating.
- Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
- The presence of distant metastatic disease was confirmed by pathology or imaging;
- has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
- In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1316 plus concurrent chemoradiotherapy Cisplatin Injection/Carboplatin Injection - SHR-1316 plus concurrent chemoradiotherapy Paclitaxel Injection - SHR-1316 plus concurrent chemoradiotherapy SHR-1316 - SHR-1316 plus concurrent chemoradiotherapy External Beam Radiotherapy (EBRT)/Brachytherapy -
- Primary Outcome Measures
Name Time Method Type, incidence and grade of drug-related adverse events of grade 3 and above Up to approximately 24 months
- Secondary Outcome Measures
Name Time Method Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug Up to approximately 30 months Objective Response Rate(ORR) Up to approximately 60 months judged based on RECIST 1.1 criteria according to Investigator's assessment
Duration of response (DoR) Up to approximately 60 months judged based on RECIST 1.1 criteria according to Investigator's assessment
12-week Complete Response Up to approximately 4 months judged based on RECIST 1.1 criteria according to Investigator's assessment
PK traits of SHR-1316: Cmax Up to approximately 24 months PK traits of SHR-1316: CL Up to approximately 24 months PK traits of SHR-1316: Vss Up to approximately 24 months Progression free survival (PFS) Up to approximately 60 months judged based on RECIST 1.1 criteria according to Investigator's assessment
PK traits of SHR-1316: AUC0-t Up to approximately 24 months Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs Up to approximately 30 months Overall Survival (OS) Up to approximately 60 months judged based on RECIST 1.1 criteria according to Investigator's assessment
2-year Progression free survival Up to approximately 24 months judged based on RECIST 1.1 criteria according to Investigator's assessment
3-year Overall Survival Up to approximately 36 months judged based on RECIST 1.1 criteria according to Investigator's assessment
PK traits of SHR-1316: Tmax Up to approximately 24 months PK traits of SHR-1316: AUC0-∞ Up to approximately 24 months PK traits of SHR-1316: t1/2 Up to approximately 24 months Serum concentration of SHR-1316 at each planned blood collection time point Up to approximately 24 months
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China